Catalog Number

-

Brand Name

Cadwell Disposable Concentric Probe

Version/Model Number

302425-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112426,K112426

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

e8584b12-2439-45b1-b9db-438d61687f6d

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

10840067100797

Quantity per Package

10

Contains DI Package

00840067100790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box